Strategize, model, decide.

A2-Ai is a premier full-service consultancy run by leaders who put science and patients first, with a focus on providing true value to our clients. Our scientists and technologists are world-class subject matter experts with decades of combined experience.

FDA Project Optimus is here

See how we leverage data-driven methods for selecting your drug dosage and treatment schedules.

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Let's get you moving faster than ever

Clinical Pharmacology

A2-Ai is the ideal partner to help navigate the complexities of clinical pharmacology. Consult with our experienced clinical pharmacologists to move your program forward.
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Pharmacometrics

Our innovative modeling and simulation approaches allow us to predict drug outcomes, assess dose/exposure-response, and expedite clinical trial design.
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Preclinical Support

Our expert preclinical scientists will help you with developing your IND, designing your topline First in Human (FIH)/First in Patient (FIP) protocol and estimating the FIH dose.
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Technology

Our customized technology tools and solutions can help identify potential drug interactions and adverse effects early on in development, allowing for adjustments to be made before costly clinical trials.
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A science-first approach

At A2-Ai, we commit to the success of our clients' programs as if they are our own. We engage early and move your assets as quickly as possible toward your corporate goals. For every project, our approach to finding solutions is always customized, personalized, and collaborative. We tailor the resources needed to support your assets and guarantee industry-leading quality standards.

Early Phase

Our early phase support includes assessment of IND packages, First in Patient dose selection, dose escalation strategy, and dose optimization support of EOP1 and EOP2 Type C meetings with the FDA or EMA. Our staff has experience across multiple therapeutic areas such as inflammation, diabetes, CNS and virology, with specific expertise in oncology.

Late Phase

Our approach is to share our extensive experience in late phase drug development with you, which includes many successful NDA/BLAs across our staff. For late phase projects, we perform all necessary quantitative pharmacometrics (PmX) analyses and prepare reports for your submission (Population PK, ER for safety, ER for efficacy, and ER for QT). We also provide medical writing services such as CSR writing and submissions document writing for SCP and SBS.

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April 1, 2025

NCA Services

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Our Non-Compartmental Analysis (NCA) of PK and PD data are designed to help you make informed, data-driven decisions quickly and accurately in real-time in your on-going studies or throughout your drug development lifecycle.

March 11, 2025

A2-Ai Cloud

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A2-Ai Cloud has been built from over a decade of supporting scientists. With A2-Ai Cloud, you can run it your way. Whether you prefer us to fully manage the platform for you or collaborate with your IT team to seamlessly deploy it into your environment, we’ve got you covered.